The particular instances discussed are the companies Amgen and Mallinckrodt, each of which recently settled Federal lawsuits claiming that they had paid kickbacks to physicians for prescribing their drugs. (Both companies, of course, denied any wrongdoing.) Dr. Poses' point, emphasized repeatedly in his blog, is that while the companies had their hands slapped--Mallinckrodt was fined $3.5M, which I think is the sort of chump change drug company execs find in their sofa cushions-- no actual human being was found guilty or had to suffer any consequences.

The point I'd make for our blog is slightly different. When I wrote HOOKED and started to write this blog I adhered to the usual custom, and described the goodies that docs received from drug firms with labels such as "gifts." After a while, I decided that I was actually aiding and abetting the practices I wished to criticize by not calling them by their true name--bribes. See for instance:http://brodyhooked.blogspot.com/2007/11/framing-problem-and-physician-bribery.html

It is somewhat reassuring to see from these recent cases that the word "bribe" is, in fact, the correct descriptor at least some of the time.

"My line of work," in this case, is arguing that physicians and their professional societies ought to step up to the demands of professionalism and take leadership in stopping the overuse of medical interventions that provide no patient benefit, might do harm, and waste a lot of money. The present survey of attitudes among a national sample of physicians is nonreassuring in several ways. Physicians generally point the fingers at others as being much more responsible for doing something about excessive medical costs (those evil trial lawyers, of course, being right at the top of the list). And while most policy wonks think we'll do nothing to reduce the overuse of worthless procedures until we reform the fee-for-service system of payment, physicians are quite solidly stacked against any such changes in reimbursement.

I'll pass on those comments for now, however, and simpy focus on a couple of questions that seemed relevant to the theme of this blog.

First, while physicians were happy to dodge the bullet on responsibility for reducing health costs, with only 36% of the sample admitting that practicing physicians had a major responsibility for this, 56% of them said that pharmaceutical and device manufacturers had such a major responsibility--suggesting that a lot of physicians held these people responsible for a good deal of high health costs. (Only 5% said these companies had no responsibility.)

Next, when asked what measures they might approve of to reduce health costs, "Limiting corporate influence on physician behavior" received a 63% "very enthusiastic" rating and an additional 27% "somewhat enthusiastic." So again, the vast majority of physicians seemed to agree that it would be a good thing if corporate influence were limited as a way of controlling costs.

So there appears to be some evidence that we pharmascolds have had some impact on physician attitudes in recent years.

Drs. Steinbrook and Redberg were waxing optimistic about new measures to improve the trustworthiness of the medical research literature. Among the reasons for optimism, they listed: "Finally, as of January 2014, the European Medicines Agency (EMA) will publish clinical trial data for the medications it considers for approval. ... Two companies have recently mounted legal challenges to decisions by the EMA to grant access to documents. But if the agency is able to keep to its timetable and fulfill its promises, a new era of access to clinical trial data will commence."

The Guardian in the UK now reports:http://www.guardian.co.uk/business/2013/jul/21/big-pharma-secret-drugs-trials
--that the drug industry is not exactly taking this threat of increased transparency in drug research lying down: "The pharmaceutical industry has "mobilised" an army of patient groups to lobby against plans to force companies to publish secret documents on drugs trials....The strategy was drawn up by two large trade groups, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA), and outlined in a memo to senior industry figures this month, according to an email seen by the Guardian."

Appropriate comments on this move are provided by Tim Reed of Health Action International, a group that has been active in exposing financial connections between drug companies and patient organizations:

"It underlines the fact that patient groups who are in the pay of the pharmaceutical industry will go into battle for them. There's a hidden agenda here. The patient groups will say they think it's a great idea to keep clinical trials data secret. Why would they do that? They would do that because they are fronts for the pharmaceutical industry.

"Patient groups get traction because they are assumed to represent the voice of the suffering. But industry uses them to say we're not going to get innovative medicines if the industry is deterred from investing by having to be transparent about their clinical trials..."

When this apparently secret campaign was brought out into the open, the responses of the drug firms and their lobbying organizations was interesting. The drug companies basically either did not reply to the Guardian or else said, "Who, us? We would never do such a thing." The lobbying organizations, PhRMA and EFPIA, brazened it out by insisting that there are serious risks to public and patient health if these trial results are openly available, and so they are just protecting their public health mandate by objecting.

According to The Guardian, the campaign seems to be working so far: "A source in the European parliament, who is close to the negotiations over the clinical trials directive, said he had experienced intense lobbying from patient groups. 'We've witnessed this sort of activity in recent months, and it's a concern if the pharmaceutical industry is behind some of it. They are trying to weaken some of the transparency proposals and that's clear from the amount of lobbying we've had,' he said."

In HOOKED, I explained the origins of the industry-insider term "astroturf" to designate a phony grass roots organization, which appears to be transmitting the real thoughts and ideas of real people, when in fact it is nothing but a PR mouthpiece for the drug industry, bought and paid for. At first I meant by "astroturf" a genuinely phony organization, that actually had no membership and was solely the creation of industry PR firms. This example from Europe suggests that we need to extend the concept and note that even real patient organizations, that actually do represent people suffering from particular diseases, can turn themselves into "astroturf" when they are willing to serve as paid shills in instances like this one.

After so many years of totally ignoring the RUC, it's nice to see the American media finally doing a lttle bit of piling on.

The focus of this recent investigative piece is one aspect of the resource-based relative value scale (RBRVS) calculation that the RUC is supposed to be reviewing and updating regularly--the amount of time that a medical procedure takes, on average. The reporters first looked at the RBRVS calculations for common procedures in gastroenterology, ophthalmology, orthopedics, and some other specialties who routinely work in outpatient surgical centers. They then looked at the publicly available records of such centers in Florida and Pennsylvania to see how many procedures were performed each day.

Given the fact that the RUC bases its calculations mostly on surveys of the specialists doing the procedures, who are told up front that their responses will be used to set reimbursement rates for their specialty, you may not be surprised to hear that in virtually all cases, the RBRVS formula overestimates the time required to do a procedure, often by a factor of two. According to the figures the RUC has come up with, a lot of specialists working in outpatient surgical centers put in 12-hour days, despite the fact that the centers are not open that many hours. A few intrepid souls manage to do more than 24 hours' worth of procedures each day.

In fairness, the time required for a procedure is only one of several factors the RBRVS takes into account in deciding how many value units to assign to that procedure. But as the factors are multiplied together, if you overestimate the time, it is hard to fully correct for that.

The CMS folks, when this is pointed out to them, respond by saying that they are now relying less and less on RUC to set their own rates. But that means that while they used to accept the RUC's recommendations wholesale 90 percent of the time, they now accapt them only 70 percent of the time. I think you could call that baby steps.

CMS has also protested all along that however flawed the RUC system might be, they simply don't have the staff or funding to decide these things independently. Which is true; according to the Post story, CMS has only 7-8 people working part time on RBRVS calculations.

However, if you look to see what Whoriskey and Keating did to calculate their numbers, it is hardly rocket science; and had they had the in-house access to the numbers that CMS must have, it would have been even easier to show that the RUC calculations were simply ridiculous. It is hard to imagine that no one at CMS, over all these years, could have observed this same thing.

Whoriskey and Keating interviewed Dr. Amrit Narula, a gastroenterologist and owner-operator of an endoscopy clinic in Pottsville, PA. The three doctors who worked there took in $700,000 for doing colonoscopies alone in 2011, while the facility charged its own separate fees and showed a profit of $1.5M. Dr. Narula, the reporters noted, lives in a 5000-square-foot house in the community.

Dr. Narula was obviously a bit embarrassed by the way he and his colleagues rake in money off a procedure that's paid much more generously in the U.S. than in any comparable industrial nation, thanks largely to the RUC. But he also pushed back a bit: “'What is the right price?... Who can tell? A lawyer can charge $400 an hour. My accountant charges me for 15 minutes of time even if he just opens an e-mail from me. And what about the bankers? . . . Ultimately, this is for society to decide.'”

Dr. Narula has a good point. And if it's for society to decide, it should be done in an open forum, not behind closed doors and under the control of the same medical specialists who are paid according to the resulting formulas.

ADDENDUM 7/22/13: As this blog is about ethics and professionalism in medicine, it may be worth taking a minute to reflect on the career of the RUC. As this and previous posts indicate, when the RUC and its activities and processes are brought out into the light of day, there is a distinct aroma problem--what's going on doesn't pass the sniff test. It seems quite obvious to any members of the general public who take the time to inform themselves about these activities (all seven of them) that what's going on sounds more like corruption and extortion than how a supposedly "professional" organization ought to conduct its business.

The AMA was fat and sassy during a good part of the 20th century. The vast majority of American physicians were AMA members (you were considered a sleazeball if you were not a member of your county medical society, and for decades you were not allowed to be a member of the county and state societies unless you also joined the AMA). The AMA was one of the most powerful lobbies in Washington and was credited single-handedly with shooting down Truman's efforts at national health insurance; in the 1948 elections more than 90 percent of all Congressional candidates whom the AMA supported got elected. Most people had high praise for physicians and for the new advances in medical sciences, and credited the medical "profession" with standing for those advances for the good of everyone. Physicians still worked incredibly long hours and made house calls, and most of them drove Chevys, not BMWs.

By the 1980s and 1990s, this halo was starting to tarnish. The AMA was starting to lose dues as legal rulings prevented automatic membership requirements--sinking to the present level where fewer than a quarter of US physicians are members of the AMA. (Full disclosure: I am not and never have been.) Historians gradually gained attention as they rewrote the history of 20th century medicine, not as Ben Casey and Dr. Kildare selflessly saving lives, but as a powerful guild making more and more money, exercising more and more power, and justifying it all on the charade that everything was done for the public good and nothing was done for selfish reasons. The public noted that physicians' incomes suddenly took off like gangbusters after Medicare and Medicaid were passed and so many previous "charity" patients suddenly had decent insurance.

So in this environment, if you'd asked any thoughtful person what was going to happen if the AMA took over the RUC and ran it strictly for the financial bennies that accrued to physicians--and then, only for one segment of physicians, the procedural specialists--and the public interest be damned, then what was going to happen? And the answer would be--maybe for a while, maybe for a long while no one will notice. But when they do, some pretty serious chickens are coming home to roost. And the result won't be pretty for those who are trying to defend American medicine as something vaguely resembling a "profession."

So they could have connected the dots and been warned. But no, they had to succumb to greed. As the old folk song said, when will we ever learn?

Thursday, July 18, 2013

When I started doing research for HOOKED, one of the first books I came across was by the Australian business sociologist John Braithwaite, whose 1984 volume bore the catchy title Corporate Crime in the Pharmaceutical Industry. Recently, I recommended this book to a colleague interested in the international pharmaceutical trade, but apologized for suggesting such an old and possibly out-of-date source. While Braithwaite focused a lot on the bribes Western drug companies paid in developing nations to push their products and evade regulation, I figured a lot must have changed since 1984 and that the situation must be a lot better.Turns out I should not have worried about being out of date.According to Katie Thomas in the New York Times:http://www.nytimes.com/2013/07/17/business/global/for-drug-makers-china-becomes-a-perilous-market.html?hp&_r=1&--some of the same drug companies whose illegal activities have landed them in hot water in the U.S. are up to similar tricks internationally, and the Chinese government, in particular, is trying to rein them in.Thomas tells us that as the Chinese pharmaceutical market blooms (with 95% of Chinese now having health insurance, probably a better percentage than in the US) and as China tries to position its own companies to compete more effectively with transnational Pharma, “selling pharmaceuticals and other health care products in China is increasingly fraught with peril, as shown by accusations in China this week that GlaxoSmithKline funneled payments through travel agents to doctors, hospitals and government officials to bolster drug sales in the country. “Chinese officials have compared the company’s operations to organized crime…”Is it strange that GSK, in particular, should have been caught doing these questionable things? “GlaxoSmithKline has been struggling to rebuild its image after a $3 billion fine in the United States last year, in which the company admitted to improperly promoting its antidepressants and failing to report safety data about the diabetes drug Avandia. Andrew Witty, who took over as chief executive in 2008, has repeatedly pitched the company as a global leader in ethical practices and said it had moved on from its previous lapses.”As part of “rebuilding its image,” GSK issued a contrite statement in response to these recent charges: “In a statement, Glaxo said it was ‘deeply concerned and disappointed’ by the accusations. ‘GSK shares the desire of the Chinese authorities to root out corruption,’ the company said, adding that it had stopped its relationships with the travel agencies identified in the investigation and was reviewing past transactions with them. ‘These allegations are shameful and we regret this has occurred.’”Following the superb precedent set by the Claude Rains character in Casablanca, I think the correct term that one is “shocked, shocked” to discover these corrupt practices going on in a morally pristine operation.But the claim to have been caught by surprise by these revelations—that apparently a few loose cannon were free-lancing without the knowledge of any company higher-ups—starts to ring hollow according to observers quoted by Thomas such as attorney Richard L. Cassin: “[T]he accusation by Chinese authorities that Glaxo channeled as much as 3 billion renminbi (about $489 million) through more than 700 travel agencies makes this case more egregious than most. ‘The question of 700 travel agencies, it’s an astounding number,’ he said.”Thomas also tells us that despite the strong growth of the Chinese national pharmaceutical industry, “some believe Western companies will have an edge because consumers may be willing to pay more for brands that are known for high-quality ingredients. “‘There are so many drugs that are poor quality in China, so the ability to differentiate yourself is important,’ said Craig A. Wheeler, the chief executive of the American generic drug maker Momenta Pharmaceuticals. His company is developing complex drugs known as biosimilars through a business deal with Baxter, which has an established presence in China.”Now, let me get this straight—as we posted a while back:http://brodyhooked.blogspot.com/2011/09/none-dare-call-it-corruption.html--when 21 Americans died in 2007 after taking contaminated heparin made with sub-par Chinese ingredients from uninspected factories, wasn’t it Baxter that sold the product? And these are now the people who claim to have the superior-quality drugs that the Chinese ought to buy instead of their own home-made products?So I guess I won’t toss my copy of Braithwaite’s book on the recycle pile just yet.

There are a
couple of take-home messages from this latest round, so bear with me.

First
message: Dr. Poses tells us about the most recent survey conducted by Transparency
International, whose work he’s been following since 2006 and which I refer to
in my own posts above. Critical findings for the US are that 43% of Americans
think that the US health care system is corrupt. If you think that’s OK, you
can contrast with the two horrible “socialized” countries, who are often held
up as examples of the depths to which America would sink if we ever allowed the
government to “take over” health care and actually guarantee every citizen
access to basic health services. The respective judgments of corruption in the
health system are 24% in Canada and 19% in the UK. On the other hand, in
fairness, at least one country in Europe with a health system often held up as
a model we should consider emulating does seem to have equivalent problems,
with 48% of Germans thinking their system is corrupt. (France is better than us
at 28%; Japan is slightly worse at 47%.)

This is
against the background of a problem that the US shares with much of the rest of
the world. Most people in most countries think two things—first, that
corruption is getting worse and not better; and second, that the institutions
that are supposed to support democracy, notably political parties, are among
the most corrupt aspects of society. In the US that means that 60% say
corruption has increased over the last 2 years and 64% say that the US
government is run by a few big special interests and not by what’s good for the
people.

Now, just to
elaborate this message a bit more, why on earth would Americans think their
health care system is corrupt? Dr. Poses also provides us in his blog with a
snapshot of one possible reason (why only “possible” we’ll see in a minute):

Dr. Poses
contrasts the praise that John Reynolds earned in 2005 when he stepped down
after many years as CEO of the Hospital for Special Surgery in New York, where
incidentally he earned a cool $1.3M in his last year on the job, with his
recently pleading guilty to two felony charges for taking illegal kickbacks
from vendors while hospital CEO:

As Dr. Poses
notes, no one at the Hospital for Special Surgery appears to have rethought the
praise for the outstanding leadership and vision that Mr. Reynolds provided for
the institution, nor questioned the size of his paycheck, or in any way
accepted that this episode represents a black eye for the hospital.

OK, now for
the second message—what Dr. Poses stresses in both of his blog posts is how the
US news media has been almost silent on this story. Regarding the little story
about Mr. Reynolds pleading guilty, only a couple of tabloids picked up on the
Bloomberg News announcement. On the primary story about the recent corruption
survey, the major US media outlets either ignored the news completely, or else
reported only on corruption in other countries, and failed to mention any of
the US statistics.

Why is this,
you might ask? Well, I tried to provide the answer in yet another previous
post:

So long as
the US popular and political culture is in the throes of the belief system some
call economism
(and others call neoliberalism), it will simply not do to talk publicly about
corruption. According to economism, the private sector can do no wrong and
everything bad comes from government interference in the “free market.” So
corruption is a taboo topic for several reasons. First, if corruption is
rampant, then powerful interests are controlling the market and it’s not really
free. Second, if corruption occurs both within corporations, and if corporations
in turn corrupt the political process, we can no longer pretend that the
private sector is pure and blameless. Third, to do something serious about
corruption would require more—gasp—government regulation, while everyone loyal
to the economism creed is aware that government regulation is never the right
answer to any problem.

So, until we
make inroads to the stranglehold that economism has on our public and political
dialogue, don’t expect our media (who are controlled more and more by a few
powerful business interests) to notice anything about corruption in
America—especially not in our health system.

I explained
how this committee, which is run pretty much secretly by the AMA but which has
a huge influence over how Medicare and Medicaid reimburses doctors, is rife
with commercial conflicts of interest, in addition to all its other problems—specifically,
being immensely top-heavy with procedural subspecialists who can almost always
outvote the primary care representatives to assure that the US health system
keeps paying tons of money for procedures and specialty care while a dwindling
handful of medical students are now entering careers in primary care, despite
the growing need for the latter.

A bit more
light has been shed on the workings of this group by Haley Sweetland Edwards in
the Washington Monthly:

Edwards was
able to get several current RUC members to talk with her as well as former RUC
members and former administrators of the Federal Center for Medicare and
Medicaid Services (CMS). (Members of RUC have to sign what amounts to a
draconian gag order.) She pulls no punches in describing how corrupt this
system is, where we basically ask the people who are going to get paid to
decide what counts as a “fair” rate to pay them at, and to do it secretly
behind closed doors.

The concerns
that I raised in the earlier post are reinforced in Edwards’s account. Many of
the physicians who sit on the RUC and represent the various subspecialty
societies may have conflicts of interest with drug and device firms that make
profits off the procedures that these physicians perform. These companies make
a lot more profits if more and more physicians do more and more of these
procedures, so there’s a huge financial incentive for the companies to lobby
for higher reimbursement rates for those same procedures. Even if the
individual physicians don’t have financial ties to the company, the same companies
are often huge donors to the specialty societies themselves. As the companies
want to make bigger profits, and the specialist docs want to all get paid more,
there’s a uniformity of interest in favor ofraising the rates for these procedures and stiffing the poor docs who
don’t do procedures and only spend time talking with patients and thinking.

As I reported
in the past, while the average person (indeed the average American physician)
has no idea that the RUC even exists, there has been an occasional drumbeat of
protest. Why imagine that now anything is going to change, since this secret
cabal has been having its way pretty much all along without challenge? Edwards
notes that there is finally some pushback, with the CMS actually starting to
reject some of the RUC’s recommendations. (Approval rates are down to about 60%
from a long-time high of 90%.)

I am hoping
Edwards’s piece will get some of the attention that it deserves because it now
comes along following a series of major articles on out-of-control prices for
US health care services and products, most notably Steven Brill’s epic article
in Time, “Bitter Pill:”

With more and
more people becoming aware that prices in hospitals are being fixed in ways
that no semblance of a “marketplace” could ever explain or justify, then
Edwards’s account of RUC, which several experts describe as nothing more or
less than a price-fixing scheme, might start to make more sense.

I will repeat
here my own disappointment with one member of the lonely primary care
contingent on RUC, my own American Academy of Family Physicians. In recent years,
aware of the huge gap between primary care and specialist income and how this
is driving a future shortage of primary care docs, the RUC has tossed a few
crumbs in the direction of primary care, and no doubt these few crumbs have
been used by the AAFP as justification for keeping its seat at the table. I
will repeat my own fervent wish that the AAFP, and any other organization on
RUC that represents primary care and has some smidgeon of integrity, will walk
away and refuse to be a part of this charade any more. The AMA has been able to
market itself to CMS as the natural organization to run RUC (for which service,
Edwards informs us, it gets paid $7M/year) in part because it can claim that it
has representatives from all the involved groups of physicians. If any
significant group were to walk away, the AMA could no longer make this claim
and its house of cards would collapse. And finally, the Feds might be forced to
appoint an actual government advisory body to set reimbursement rates, and to
do so according to open procedures with full disclosure of conflicts of
interest.

--about the
search for a new drug that has the pharmaceutical industry all pumped up, and
that indeed represents an exciting tale of medical progress.

I already
don’t like the way this post is going to sound, so I’ll start backpedalling
right off. I don’t want to sound like I am hoping that a promising new drug
possibility ends up going bust. I don’t want to sound like I am hoping that
people at risk for serious heart disease, who might be aided by this new drug,
won’t be helped. But…

The exciting
part of this story is that the promise of new therapies from mapping the human
genome has thus far not produced anything like what it was hyped, but
proponents have all along been saying, “Just wait.” And it does seem like this
story depends on recent discoveries that allow a large number of people’s
genomes to be put on the web and searched quickly with sophisticated software.
Scientists became aware of a rare gene mutation that causes a very low level of
LDL (bad) cholesterol. We know the higher your LDL, the greater your risk of
having a heart attack or stroke, and vice versa.

Three drug
companies, Amgen, Pfizer, and Sanofi, have been able to develop new drugs that
appear to mimic the effects of this gene mutation. People taking the drugs in
early tests have seen plummeting levels of LDL to points nearly
undetectable—leading to concerns that some harm might even be caused as no
physician sees such low levels in actual practice. The new drugs are not
chemical but biological agents, monoclonal antibodies that have to be
manufactured in living cells. The companies are betting on their success and
developing new factory facilities that can produce unprecedented quantities of
monoclonal antibodies.

So what could
possibly be wrong with this picture?

Kolata
fingers one fairly obvious concern. In today’s drug market, monoclonal
antibody-type drugs are hugely expensive—such as some anticancer drugs. So are
we talking about a new class of designer drugs that only the Warren Buffets of
the world will be able to afford? Presumably the drug companies are trying to
answer that concern precisely by touting the huge quantities of drug their new
facilities are planned to produce. If on the other hand they marketed any such
drug at a truly affordable price—instead of trying to milk the market for every
last buck they could squeeze—it would really be a first.

If you read
far enough into the article, another concern arises. Kolata does not mention
this case specifically, but has everyone already forgotten ezetimibe?

Readers of
this blog have not forgotten, of course, because y’all recall posts like this:

Ezetimibe was
the drug contained in the brand-name products Zetia and Vytorin, and was highly
touted in its day because it had a new mechanism of action. While one way to
avoid heart disease is to have a low LDL, the other is to have a high HDL
(“good cholesterol”), which is basically the same thing as all the cholesterol
in your body is pretty much divided up into the LDL and HDL fractions.
Ezetimibe was the wonder drug of its day because it seemed uniquely able to raise
patients’ HDL, and in clinical trials, it did so quite successfully.

Only it did
nothing at all to prevent heart disease and stroke.

So the lesson
from everything we know so far about ezetimibe is that just because a new drug
has an effect on various body measurements that mimic stuff which, when it
happens naturally, is associated with lower risk of heart disease, doesn’t mean
that the drug automatically prevents heart disease. You have to do longer-range
trials to look and see whether it actually has such an effect. In the case of
ezetimibe, I suggested in this other post:

--that the
real take-home message might better be to have doubts about the whole theory
that lowering cholesterol prevents heart disease—that statin drugs, for
example, if they work to reduce the risk of a second heart attack after you’ve
had a first (as they seem to), might well do so by reducing inflammation or
something else, not by lowering cholesterol.

So maybe when
they test out these new monoclonal-antibody drugs, they will be shown to really
reduce the risk of heart attack, stroke, and death, and not merely to make
one’s lab numbers look pretty. And maybe then the new drugs will also prove to
be safe and not have nasty side effects. And maybe also the companies will
actually manufacture them at a reasonable cost so that regular folks can afford
them.

Maybe. But
you can see why some would not be willing to put money on it.